NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION— 510(k) K971774
Substantially EquivalentNsk Nakanishi, Inc.
FDA 510(k) clearance K971774 for NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION, Substantially Equivalent on 1997-06-20. Applicant: Nsk Nakanishi, Inc.. Device class: 1.
Clearance details
- Applicant
- Nsk Nakanishi, Inc.
- Product code
- Product code EFB
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tochigi-Ken, JP
Recent devices under product code EFB
view all- K260029 — Firstar Dental Handpieces
- K262144 — DIAMED Handpiece; DIAMED Airmotor; DIAMED Airmotor Handpiece
- K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
- K251389 — High speed air turbine handpiece
- K242179 — Synea Fusion Handpieces (Intensiv & Profin)
More clearances from Nsk Nakanishi, Inc.
view all- K991701 — MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)
- K991021 — SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
- K990954 — ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
- K990682 — PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)
- K990646 — PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE
Adverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.